The following data is part of a premarket notification filed by Buhlmann Laboratories Ag with the FDA for Buhlmann Angiostensin Ii Ria.
| Device ID | K954299 |
| 510k Number | K954299 |
| Device Name: | BUHLMANN ANGIOSTENSIN II RIA |
| Classification | Radioimmunoassay, Angiotensin I And Renin |
| Applicant | BUHLMANN LABORATORIES AG P.O. BOX 451 Windham, NH 03087 |
| Contact | Richard E Conley |
| Correspondent | Richard E Conley BUHLMANN LABORATORIES AG P.O. BOX 451 Windham, NH 03087 |
| Product Code | CIB |
| CFR Regulation Number | 862.1085 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-14 |
| Decision Date | 1995-10-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EBUHRKA221 | K954299 | 000 |